Feasibility research of setting ISO international standard of Sinomenii Caulis based on the literature / 国际中医中药杂志

ABSTRACT

To conduct research and stipulate international standards of Chinese herbal medicine under the guildance of International Organization for Standardization (ISO) has become a new hot spot of internationalization and standardization of traditional Chinese medicines. International organization for standardization/technical committee of traditional Chinese medicine (ISO/TC249) provides a international platform to develop the standards of Chinese herbal medicine. Sinomenii Caulis, as a traditional Chinese medicine with obvious clinical effect which is used internationally, it’s necessary to establish a unified quality and safety control standards at international level. The current literature showed that there are many aliases of Sinomenii Caulis, and the problem of its variety confusion and adulteration is serious. Sinomenine-based alkaloids were the main pharmacological active components of Sinomenii Caulis. By analyzing the pharmacopoeias of China, Japan, South Korea and Europe, it was found that both Chinese and European Pharmacopoeias take sinomenine as the quality control indicator of Sinomenii Caulis. The Japanese and South Korean pharmacopoeias had similar quality control requirements of Sinomenii Caulis, and the South Korean pharmacopoeia pays more attention on safety requirements. Thus, it is suggested that setting ISO standards of Sinomenii Caulis requires the collection of global trade data and samples of Sinomenii Caulis for future quality and safety research.